Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
|ClinicalTrials.gov Identifier: NCT01697423|
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : October 2, 2012
Last Update Posted : November 10, 2015
The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The aim of the treatment of symptomatic osteoarthritis consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients.
The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular injections are proposed.
Intra articular injections of hyaluronic acid are recommended by the American College of Rheumatology and the European League against Rheumatism for the treatment of knee osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the duration of clinical improvement which does not exceed 6 months.
The articular cartilage has a limited capacity for self-repair due to the low mitotic activity of chondrocytes and its avascularity.
Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and the cytokines, liberated by platelet degranulation. The influence of these growth factors in the cartilage repair is being widely investigated in vivo and in vitro. These factors could stimulate the chondral reparation via a neovascularization, a collagen synthesis and an activation of the chondrocytes.
The hypothesis is that the intra articular injection of PRP, with its capacity to enhance articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the treatment of knee osteoarthritis resisting the oral drugs.
Material and methods: We intend to conduct a comparative, monocentric prospective randomized, double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.
|Condition or disease||Intervention/treatment||Phase|
|the Treatment of Knee Osteoarthritis||Drug: platelet-rich plasma Drug: durolane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
|Experimental: platelet-rich plasma||Drug: platelet-rich plasma|
|Active Comparator: durolane||Drug: durolane|
- Variation of the functional score of WOMAC [ Time Frame: 12 months ]evaluate the non inferiority between platelet-rich plasma (PRP) and hyaluronic acid. onthé evolution of the knee function, by assessing the difference with a functional score (WOMAC), before and 3 months after treatment.
- the evolution of pain [ Time Frame: 12month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697423
|Contact: marie laure LOUISfirstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: MARIE LAURE LOUIS|
|Principal Investigator: MARIE LAURE LOUIS|
|Study Director:||BERNARD BELAIGUES||Assistance Publique Hopitaux De Marseille|
|Principal Investigator:||marie laure LOUIS||AP HM|